Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088168
Company: FOUGERA PHARMS INC

Products on ANDA 088168

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.025%	OINTMENT;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088168

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/1982	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/28/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/28/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/09/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088168

FLUOCINOLONE ACETONIDE

OINTMENT;TOPICAL; 0.025%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.025%	OINTMENT;TOPICAL	Prescription	No	AT	089524	COSETTE
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.025%	OINTMENT;TOPICAL	Prescription	No	AT	088168	FOUGERA PHARMS INC
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.025%	OINTMENT;TOPICAL	Prescription	No	AT	040041	TARO
SYNALAR	FLUOCINOLONE ACETONIDE	0.025%	OINTMENT;TOPICAL	Prescription	Yes	AT	013960	MEDIMETRIKS PHARMS